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杨净思, 陈洪波, 杨晓蕾, 杨伟, 丁雪凤, 张云昆, 潘玥, 张鸣. H2株甲肝减毒活疫苗安全性及免疫效果观察[J]. 中国公共卫生, 2005, 21(10): 1186-1187.
引用本文: 杨净思, 陈洪波, 杨晓蕾, 杨伟, 丁雪凤, 张云昆, 潘玥, 张鸣. H2株甲肝减毒活疫苗安全性及免疫效果观察[J]. 中国公共卫生, 2005, 21(10): 1186-1187.
YANG Jingsi, CHEN Hongpo, YANG Wei, . Observation on safety and immune effect of live attenuated Hepatitis A vaccine(H2 strain) with suspension absorption technique in rhesus monkey[J]. Chinese Journal of Public Health, 2005, 21(10): 1186-1187.
Citation: YANG Jingsi, CHEN Hongpo, YANG Wei, . Observation on safety and immune effect of live attenuated Hepatitis A vaccine(H2 strain) with suspension absorption technique in rhesus monkey[J]. Chinese Journal of Public Health, 2005, 21(10): 1186-1187.

H2株甲肝减毒活疫苗安全性及免疫效果观察

Observation on safety and immune effect of live attenuated Hepatitis A vaccine(H2 strain) with suspension absorption technique in rhesus monkey

  • 摘要:
      目的   观察单层及悬浮吸附工艺不同收毒时间生产的H2株甲型肝炎减毒活疫苗(以下简称甲肝活疫苗)接种恒河猴的安全性及免疫效果。
      方法   筛选甲肝抗体阴性, 丙氨酸转胺酶(ALT)正常的恒河猴15只, 随机分为3组, 每组5只, 下肢静脉注射疫苗1 ml/只。接种3 d内, 每天观察有无局部和全身反应, 0, 2, 3, 4, 6, 8周采血测ALT及甲肝抗体, 0, 4, 8周肝穿做组织病理检查, 观察到期尸检。
      结果   接种疫苗3 d内, 所有恒河猴均无局部和全身反应。观察全程ALT正常, 肝脏无特殊组织病理改变。免后4周甲肝抗体全部阳转, 单层工艺26 d疫苗、悬浮工艺23和26 d疫苗几何平均滴度(GMT)4周分别为9.2, 14.9和27.9;8周分别为32, 64和64;悬浮工艺23 d和26 d疫苗猴体免疫效果相似, 且两者均明显优于单层工艺疫苗。
      结论   悬浮吸附工艺23 d收毒疫苗接种恒河猴具有较好的安全性和可靠的免疫效果, 采用悬浮吸附工艺生产H2株甲肝活疫苗23 d收获病毒较经济和稳妥。

     

    Abstract:
      Objective   To observe the safety and immune effect of live attenuated hepatitis A vaccine(H2 strain)produced by mono-layer absorption and suspension absorption with different virus harvest period in rhesus monkeys.
      Methods   Fifteen rhesus monkeys with negative anti-HAV and normal level of alanine transaminase(ALT)were selected and divided randomly into 3 groups. A group of 5 animals for 1 specimen and 1ml of vaccine was injected by Ⅳ into each rhesus monkey. The local and systemic reactions were observed within 3 days after injection. Both anti-HAV and ALT were detected at wk 0, 2, 3, 4, 6, 8 and liver puncture was performed at wk 0, 4, 8 for histopathological examination. Autopsy was down at the end of observation.
      Results   No local and systemic reactions were observed in any rhesus monkeys within 3 days after vaccination, The ALT levels were normal and no specific liver histopathological change were examined during whole period. The seroconversion rate of anti-HAV was 100%at 4 wk after inoculation. The GMTs were 9.2, 14.9, 27.9 for mono-layer absorption vaccine(26 d harvest), suspension absorption vaccine(23 d harvest) and suspension absorption vaccine(26 d harvest)at 4 wk and 32, 64, 64 at 8 wk. The immune effects induced by 2 suspension absorption vaccine were similar, but better than that mono-layer absorption.
      Conclusion   Suspension absorption with 23 d harvest technique vaccine possesses good safety and immune effect in rhesus monkey inoculation. The application of suspension absorption(23 d harvest)technique for production of hepatitis A vaccine(H2 strain)is economic and practicable.

     

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